Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

This study has been completed.
Sponsor:
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00694213
First received: June 6, 2008
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.


Condition Intervention Phase
Influenza
Biological: VCL-IPM1
Biological: VCL-IPT1
Biological: PBS
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System

Resource links provided by NLM:


Further study details as provided by Vical:

Primary Outcome Measures:
  • Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: August 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: VCL-IPM1
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
Experimental: 2 Biological: VCL-IPM1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Experimental: 3 Biological: VCL-IPT1
IM, 1 mg/mL, 2 injections, 0 and 21 days
Placebo Comparator: 4 Biological: PBS
IM, 1 mL, 2 injections, 0 and 21 days
Other Name: Phosphate Buffered Saline

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 45 years of age
  • Able to provide informed consent and be followed for 6 months

Exclusion Criteria:

  • No immunomodulatory therapy within the past 6 months
  • No evidence of immunodeficiency or pregnancy
  • No laboratory or evidence of clinically significant medical disease
  • No history of previous pDNA immunization
  • No influenza immunization within the past 30 days
  • No blood donations within 30 days of screening visit
  • No history of bleeding disorder
  • No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694213

Locations
United States, California
Accelovance
San Diego, California, United States, 92108
United States, Maryland
SNBL
Baltimore, Maryland, United States, 21201
United States, New York
SUNY at Stonybrook, Stony Brook Medical Center
Stony Brook, New York, United States, 11794-8153
Sponsors and Collaborators
Vical
Investigators
Study Chair: Don Guterwill, BS, MT Vical
  More Information

Additional Information:
No publications provided

Responsible Party: Don Guterwill, BS, MT, Senior Clinical Project Manager, Vical Incorporated
ClinicalTrials.gov Identifier: NCT00694213     History of Changes
Other Study ID Numbers: IPT1-102
Study First Received: June 6, 2008
Last Updated: February 11, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Vical:
Pandemic Influenza
Avian Influenza
DNA Vaccines
Antibody
T Cells
HA/NP/M2
Biojector

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014